What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy can cause side effects such as nausea, vomiting, hair loss, fatigue, and increased risk of infection. Targeted therapies, which inhibit specific molecules involved in cancer growth, may lead to side effects like skin rash, diarrhea, and liver toxicity. Immunotherapy, which boosts the body's immune response against cancer cells, can result in immune-related adverse events such as colitis, pneumonitis, and thyroid dysfunction. These side effects vary in severity and frequency among patients.

What prior FDA approvals exist?

Several FDA-approved treatments for advanced Non-Small Cell Lung Cancer (NSCLC) include immune checkpoint inhibitors and targeted therapies. Pembrolizumab, an anti-PD-1 therapy, has shown significant efficacy in improving overall survival and progression-free survival in combination with chemotherapy for advanced NSCLC. Atezolizumab, another immune checkpoint inhibitor targeting PD-L1, is approved for use in combination with chemotherapy for both squamous and non-squamous NSCLC. Additionally, targeted therapies like Sotorasib and Adagrasib, which specifically target the KRAS G12C mutation, have been approved for patients with advanced NSCLC who have received prior systemic therapy. These treatments represent significant advancements in the management of advanced NSCLC, offering new options for patients with specific genetic profiles or those who have progressed on traditional therapies.

What other types of research exist?

Promising novel alternatives for NSCLC patients include: 1) Crizotinib, which has shown superiority over chemotherapy in ALK-positive advanced NSCLC. 2) BTK inhibitors like ibrutinib and acalabrutinib, which are effective in certain genetic profiles. 3) Pembrolizumab plus cetuximab, which is being investigated for treatment-refractory metastatic head and neck cancer and may have applications in NSCLC. 4) Multitargeted kinase inhibitors such as regorafenib, cabozantinib, sorafenib, and lenvatinib, which have shown limited activity in advanced cancers. These alternatives are based on recent clinical trials and ongoing research.

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HC-7366 for Advanced Solid Cancers

Phase 1

Waitlist Available

Research Sponsored by HiberCell, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male subjects with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or for the time their partner is breastfeeding throughout the study treatment and for 90 days after the final administration of study drug

Have not experienced >10% body weight loss in the previous 4 weeks

Must not have

Has overt or latent disorders of the exocrine pancreas or chronic gastrointestinal disorders

Has a history of interstitial lung disease, pneumonitis within 12 months prior to screening, or current pneumonitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 18 months of last patient enrolled

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new oral medication called HC 7366 in patients with advanced solid tumors. The goal is to find the safest dose and see how well patients tolerate it. The study adjusts the dose to determine the best amount that can be given without causing severe side effects.

Who is the study for?

This trial is for adults with advanced solid tumors, including specific cancers like head and neck squamous cell carcinoma, colorectal cancer, non-small cell lung cancer, and bladder cancer. Participants must have an acceptable performance status and organ function, agree to use contraception if of childbearing potential, and not have a history of certain diseases or be on immunosuppressive therapy.

What is being tested?

HC-7366 is being tested in this study to find the highest dose patients can take without serious side effects (MTD) and the recommended dose for future Phase 2 trials (RP2D). The trial involves oral dosing in escalating amounts up to 150 mg daily. It includes initial testing (Phase 1a) followed by expansion at a fixed dose (Phase 1b) specifically in renal cell carcinoma patients.

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions due to HC-7366 during the trial. These could range from mild symptoms like nausea or fatigue to more severe issues depending on how well they tolerate the drug.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I will not have unprotected sex if my partner is pregnant or breastfeeding during the study and for 90 days after.

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I have not lost more than 10% of my body weight in the last month.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My hormone levels are normal or well-managed.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a chronic pancreas or gastrointestinal condition.

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I have had lung inflammation or pneumonitis in the last year.

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I have cancer that has spread to my brain or spinal cord.

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I am currently being treated for an infection.

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I have an active hepatitis B or C infection.

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I do not have an infection that would affect my participation in the study.

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I have an active case of tuberculosis.

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I have a serious heart condition.

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I have a known history of HIV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 18 months of last patient enrolled

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 18 months of last patient enrolled

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 18 months of last patient enrolled for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determination of MTD of HC-7366

Determination of Recommended Phase 2 dose of HC-7366

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

8Treatment groups

Experimental Treatment

Group I: Phase 1b Cohort 8 - Dose 2 Chosen for ExpansionExperimental Treatment1 Intervention

XX mg capsules of HC-7366 administered orally once a day in the fasting state with water at least 1 hour before food or at least 2 hours after food of each 3-week treatment cycle

Group II: Phase 1b Cohort 7 - Dose 1 Chosen for ExpansionExperimental Treatment1 Intervention

XX mg capsules of HC-7366 administered orally once a day in the fasting state with water at least 1 hour before food or at least 2 hours after food of each 3-week treatment cycle

Group III: Phase 1a Cohort 6 - 150 mgExperimental Treatment1 Intervention

150 mg capsules of HC-7366 administered orally once a day in the fasting state with water at least 1 hour before food or at least 2 hours after food of each 3-week treatment cycle

Group IV: Phase 1a Cohort 5 - 125 mgExperimental Treatment1 Intervention

125 mg capsules of HC-7366 administered orally once a day in the fasting state with water at least 1 hour before food or at least 2 hours after food of each 3-week treatment cycle

Group V: Phase 1a Cohort 4 - 75 mgExperimental Treatment1 Intervention

75 mg capsules of HC-7366 administered orally once a day in the fasting state with water at least 1 hour before food or at least 2 hours after food of each 3-week treatment cycle

Group VI: Phase 1a Cohort 3 - 40 mgExperimental Treatment1 Intervention

40 mg capsules of HC-7366 administered orally once a day in the fasting state with water at least 1 hour before food or at least 2 hours after food of each 3-week treatment cycle

Group VII: Phase 1a Cohort 2 - 20 mgExperimental Treatment1 Intervention

20 mg capsules of HC-7366 administered orally once a day in the fasting state with water at least 1 hour before food or at least 2 hours after food of each 3-week treatment cycle

Group VIII: Phase 1a Cohort 1 - 10 mgExperimental Treatment1 Intervention

10 mg capsules of HC-7366 administered orally once a day in the fasting state with water at least 1 hour before food or at least 2 hours after food of each 3-week treatment cycle

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies, immunotherapies, and traditional chemotherapies. Targeted therapies, such as tyrosine kinase inhibitors, work by specifically targeting and inhibiting the function of proteins that are involved in the growth and survival of cancer cells. Immunotherapies, like checkpoint inhibitors, enhance the body's immune response against cancer cells by blocking proteins that prevent immune cells from attacking the tumor. Traditional chemotherapies, such as docetaxel, kill rapidly dividing cells, including cancer cells, by interfering with cell division. These treatments are crucial for NSCLC patients as they offer different mechanisms to control tumor growth, improve survival rates, and potentially provide options when tumors become resistant to one type of therapy.